The European Medicines Agency (EMA) has published version 1.4 of the European Shortages Monitoring Platform (ESMP) User Guide for Marketing Authorisation Holders (MAHs), dated 28 April 2026. The guide provides detailed instructions for MAHs on using the ESMP to report shortages and supply information for medicinal products for human use, as required under Regulation (EU) 2022/123. The update introduces several clarifications and new features to streamline reporting and improve data quality.
Document details
The guide, issued by EMA, is a user manual for the ESMP IT platform. It is not a legally binding document but serves as a practical tool to help MAHs comply with their regulatory obligations. Version 1.4 replaces earlier versions and incorporates feedback from users and regulatory experience.
Key updates in version 1.4
For routine shortage reporting of centrally authorised products (CAPs), the guide adds reference to readable RMS IDs, provides further guidance on reporting and updating shortage notifications, and introduces automated alerts for outdated reports. For crisis and MSSG-led preparedness submissions, the guide clarifies mandatory PMS data completeness (including structured package and manufacturing data), specifies that CAP marketing status only affects generation of the Availability information template, adds readable RMS IDs, includes NAP manufacturing data from PMS in templates, and updates screenshots for alternative therapies submission.
Policy orientations and trade-offs
The updates aim to enhance the efficiency and accuracy of shortage reporting, reducing the administrative burden on MAHs while ensuring timely and complete data for regulators. However, the increased data requirements for crisis submissions may impose additional compliance costs on MAHs, particularly smaller companies. The trade-off is between improved public health preparedness and the operational burden on industry.
Impact on stakeholders
MAHs with products in the EU/EEA will need to update their internal processes to align with the new guidance, potentially requiring IT adjustments and staff training. National competent authorities will benefit from more consistent and complete data, facilitating better coordination during shortages. EMA gains improved oversight of supply chains. Patients and healthcare providers may indirectly benefit from more effective shortage management.
Expected institutional follow-up
EMA will continue to update the guide as the ESMP platform evolves. MAHs are expected to implement the changes promptly to ensure compliance with regulatory requirements. The next version may incorporate further feedback from stakeholders and lessons learned from crisis exercises.